HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance (HOWTO-BRS)

July 7, 2022 updated by: Seung-Jung Park
The objective of this trial is to compare clinical outcomes between imaging-guided and QCA-guided strategy in patients with native coronary artery disease undergoing BRS implantation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators hypothesized that intravascular imaging-guided BRS implantation is superior to QCA-guided BRS implantation with respect to target lesion failure in patients with native coronary artery disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women at least 19 years of age
  • Typical chest pain or objective evidence of myocardial ischemia suitable for elective percutaneous coronary intervention
  • Native coronary artery lesions with lesion length 50mm and less and reference vessel diameter of 2.5 ~ 3.75mm by quantitative coronary angiography assessment
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  • Angiographic exclusion criteria: any of the followings

    1. Small vessel: mean reference size < 2.5 mm by quantitative coronary angiography
    2. True bifurcation lesion with a large side branch (reference vessel diameter > 2.3mm) requiring a complex two-stent approach
    3. Left main lesions
    4. Ostial lesions within 3mm of the origin: right coronary artery, left anterior descending, or left circumflex artery

    5. Impaired delivery of the Absorb bio- resorbable vascular scaffold is expected:

      • Extreme angulation (≥90°) proximal to or within the target lesion.
      • Excessive tortuosity (≥two 45° angles) proximal to or within the target lesion.
      • Moderate or heavy calcification proximal to or within the target lesion.
    6. In-stent restenotic lesions
  • ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset)
  • Prior percutaneous coronary intervention within the target vessel during the last 12 months.
  • Prior percutaneous coronary intervention within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
  • Left ventricular ejection fraction (LVEF) < 30%
  • Hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
  • Persistent thrombocytopenia (platelet count <100,000/µl)
  • Any history of hemorrhagic stroke or intracranial hemorrhage, transient ischemic attack or ischemic stroke within the past 6 months
  • A known intolerance to a study drug (aspirin, clopidogrel or ticagrelor)
  • Patients requiring long-term oral anticoagulants or cilostazol
  • Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate(ADP) antagonist is planned within 12 months after the procedure.
  • A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times upper limit of normal).
  • Life expectancy < 5 years for any non-cardiac or cardiac causes
  • Unwillingness or inability to comply with the procedures described in this protocol.
  • Patient's pregnant or breast-feeding or child-bearing potential.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Imaging guided Bioresorbable scaffold
Device: imaging guided Bioresorbable scaffold implantation
In the imaging-guided group, imaging is used at any step of percutaneous coronary intervention(PCI) before, during, or after PCI. Final image examination after PCI is mandatory.
EXPERIMENTAL: QCA-guided Bioresorbable scaffold
quantitative coronary angiography guided Bioresorbable scaffold
Device: quantitative coronary angiography guided Bioresorbable scaffold implantation
In the QCA-guided group, BRS size and length were chosen by both visual estimation and on-line QCA, and adjunct high-pressure dilation is routinely performed to achieve angiographic residual diameter stenosis less than 30% by QCA and absence of angiographically visible dissections.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Target lesion failure
Time Frame: 1 year
the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device success
Time Frame: 1 hour after an index procedure
Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA).
1 hour after an index procedure
Procedural success
Time Frame: 24 hours after an index procedure
Achievement of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel myocardial infarction or repeat target lesion revascularization during the hospital stay.
24 hours after an index procedure
Death
Time Frame: 1 year, and 5 years
cardiac, vascular, non-cardiovascular
1 year, and 5 years
Myocardial infarction
Time Frame: 1 year, and 5 years
1 year, and 5 years
Scaffold thrombosis
Time Frame: 1 year, and 5 years
1 year, and 5 years
Stroke
Time Frame: 1 year, and 5 years
1 year, and 5 years
Target lesion revascularization
Time Frame: 1 year, and 5 years
1 year, and 5 years
Any revascularization
Time Frame: 1 year, and 5 years
1 year, and 5 years
Target lesion failure (TLR)
Time Frame: 1 year, and 5 years
cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization
1 year, and 5 years
A composite event
Time Frame: 1 year, and 5 years
a composite event of cardiac death, target vessel myocardial infarction, stroke, or clinically significant bleeding(clinically significant bleeding by Bleeding Academic Research Consortium (BARC) type 2,3,4,5)
1 year, and 5 years
In-scaffold restenosis on coronary CT angiography
Time Frame: 1 year, and 5 years
1 year, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Jung Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CardioVascular Research Foundation, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yang-soo Jang, MD, Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMCCV2017-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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